MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN; Agent, absorbable hemostatic, collagen based

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon has stopped using surgiflo due to two patients needing to be brought back to the or to clean and washout the incision site.Patients currently doing fine.Surgeon has seen no more issues since stopping the use of surgiflo on every patient.No further information was provided.

• Brand Name: SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN
• Common Device Name: Agent, absorbable hemostatic, collagen based
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 21354492
• Report Number: 3008478369-2025-00004
• Device Sequence Number: 7854522
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: 15712123000288
• Combination Product (Y/N): Y
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown